Lancet-integrated sensor, measuring device for lancet-integrated sensor, and cartridge

ABSTRACT

A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

This is a divisional application of U.S. patent application Ser. No.10/222,000, which is the National Stage of International Application No.PCT/JP02/00386, filed Jan. 21, 2002.

TECHNICAL FIELD

The present invention relates to a lancet-integrated sensor forextracting bodily fluid of a man or an animal, and easily analyzingcharacteristics of the bodily fluid and, more particularly, to animproved lancet-integrated sensor that is characterized by aconstruction in which a lancet for lancing skin to extract bodily fluidis integrated with a sensor for collecting the bodily fluid extracted ata surface of the skin to analyze the fluid.

Further, the present invention relates to a measuring device formeasuring components of bodily fluid such as blood sugar and, moreparticularly, to an improved measuring device for a lancet-integratedsensor.

Furthermore, the present invention relates to an improved cartridge forhousing biosensors of this type.

BACKGROUND ART

Conventionally, as a device for easily analyzing characteristics ofbodily fluid of a man or an animal, for example, a device forelectrochemically measuring blood sugar has already been put topractical use.

A biosensor is a device of this type, and hereinafter, a biosensor and ameasuring device to be combined with the biosensor will be described.

FIG. 21 shows a long and narrow strip-shaped sensor 31 for collectingblood, which is set in a sensor insertion slot 31 a of a measuringdevice 32. The sensor 31 is provided with a cavity (not shown) forcollecting blood, in its semi-circular front end that protrudes from themeasuring device 32 in a state where the sensor 31 is housed in themeasuring device 32. Further, the sensor 31 is provided with, in thecavity, a reagent layer containing an enzyme, an electron carrier, andthe like, and electrodes.

The measuring device 32 contains an electric circuit for measuring acurrent value according to concentration of glucose in blood, whichcurrent is generated by a reaction between the glucose in blood and thereagent layer, by applying a voltage to the electrode, and measuredblood sugar is displayed on a display 33 which is placed on an uppersurface of the measuring device 32.

For every measurement, a new sensor 31 is inserted into the sensorinsertion slot on a side surface of the measuring device 32, and bloodof a patient is applied onto the sensor 31 to perform measurement. Thesensor 31 after measurement is discarded for hygienic reasons.

Usually, skin of a body part, such as a fingertip, is lanced with alancet device 34 as shown in FIG. 22( a) to extract a very smallquantity of blood, and the blood is collected in the cavity of thesensor 31.

In the lancet device 34 whose internal structure is shown in FIG. 22(b), a force is elastically applied to a lancet 35 by a spring coil 36.When an operation button 37 is pushed, an engagement member 37 a whichis united with the operation button 37 is disengaged from a ring-shapedgroove 35 a of the lancet 35, whereby a force applied to the lancet 35by the spring 36 is released, and a tip of a needle 35 b of the lancet35 forcibly projects from a front end of an approximatelycylindrical-shaped case 38. The lancet 35 comprises the needle 35 bwhich is made of metal, and a holder 35 c for holding the needle 35 b,which is made of plastic. Usually, the lancet 35 is replaced with a newone at every measurement, for hygienic reasons.

Further, a biosensor to be used for analyzing bodily fluid extractedfrom a man or an animal is usually preserved in a state where it iswrapped with an aluminum wrapper or the like, or in a state where it iscontained in a plastic case. When the biosensor is used, it is taken outof the aluminum wrapper or the plastic case.

FIG. 23( a) is a diagram illustrating a state where a biosensor 110having a reagent layer (not shown) for analyzing bodily fluid, and anelectrode (not shown) for removing an electric signal according toresult of analysis, is hermetically wrapped with an aluminum wrapper120. To be specific, a biosensor 110 which comprises an approximatelyrectangular-shaped plate member having a shorter side of anapproximately semi-circular shape is wrapped with an aluminum wrapper120 having a rectangular shape that is a little larger than thebiosensor 110. FIG. 23( b) shows a state where a plurality of biosensors110, which are arranged with their approximately-semi-circular-shapedends facing upward and their surfaces being in contact with each other,are hermetically contained in a cylindrical plastic case 130 with a lid.

When performing measurement, the biosensor 110 which is preserved asshown in FIG. 23( a) or 23(b) is removed, and another shorter side ofthe biosensor 110, which is not the approximately-semi-circular-shapedside, is inserted into a biosensor insertion slot 114 a of a measuringdevice 114 to prepare for measurement as shown in FIG. 24.

Since the conventional biosensor and measuring device thereof areconstructed as described above, when preparing for measurement, apatient sets a new lancet 35 in the lancet device 34 as described above.Then, the patient sets a new sensor 31 in the measuring device 32,whereby preparation for measurement is completed. Thereafter, thepatient operates the lancet device 34 to take blood from his/herfingertip or the like, and applies it onto a front end of the sensor 31that is set in the measuring device 32 to perform measurement. In thisway, the patient must perform replacement of the lancet and replacementof the sensor separately for every measurement, resulting in complicatedoperation.

Further, since it is necessary to monitor blood sugar a few times a day,sizes of these devices are reduced in consideration of portability. In aconventional system, however, the patient must carry the sensor 31, themeasuring device 32, the lancet 35, and the lancet device 34 together,resulting in a voluminous system as a whole. Further, since the patientmust manage the sensor 31 and the lancet 35 separately, operation andmeasurement are troublesome, resulting in poor usability.

The present invention is made to solve the above-mentioned problems andhas for its object to provide a lancet-integrated sensor in which asensor and a lancet are integrated to facilitate operation andmanagement, and improve portability, as well as a measuring device to becombined with the lancet-integrated sensor.

Further, with respect to the conventional biosensors, as describedabove, each biosensor is wrapped with an aluminum wrapper, or pluralbiosensors are stored in a plastic case with a lid, whereby thebiosensors are prevented from contamination due to moisture.

However, when preparing for measurement, a patient must break thealuminum wrapper 120 to take the biosensor 110, or open the lid 130 a ofthe plastic case 130 to take the biosensors 110 one by one. Further, thepatient must insert this taken biosensor 110 toward the sensor insertionslot 114 a of the measuring device 114. Therefore, preparation formeasurement is troublesome, and usability is poor.

The present invention is made to solve the above-mentioned problems andhas for its object to provide a biosensor cartridge by which a biosensorstored in a case is easily inserted into a measuring device withouttroublesome operation.

SUMMARY OF THE INVENTION

To be specific, in order to solve the above-mentioned conventionalproblems, a lancet-integrated sensor according to a first aspect of thepresent invention is constituted by integrating a lancet for lancingskin of a subject to extract its bodily fluid, and a sensor body foranalyzing this extracted bodily fluid. The sensor body has a shape of along and narrow strip; and the lancet is driven along a longitudinaldirection of the sensor body by an external driving device, therebylancing the skin.

Accordingly, the sensor and the lancet are integrated with each other,whereby the sensor and the lancet can be managed not separately buttogether, resulting in easy handling. When measuring bodily fluid, sincethe sensor and the lancet can be set as a single unit on a measuringdevice, operability is improved. Further, the lancet-integrated sensoris convenient to carry about. Furthermore, since the lancet is movablealong the longitudinal direction of the long and narrow strip-shapedsensor, a size of the lancet-integrated sensor is reduced, resulting ineasy handling.

Further, according to a second aspect of the present invention, in thelancet-integrated sensor defined in accordance with the first aspect,the sensor body has an internal space through which the lancet can pass,and holds the lancet in the space.

Accordingly, the lancet is held in the sensor, thereby providing aspecific construction for further reducing the size of thelancet-integrated sensor.

Further, according to a third aspect of the present invention, in thelancet-integrated sensor defined in accordance with the second aspect, along and narrow space for housing the lancet is formed in the sensorbody.

Accordingly, the long and narrow space facilitates positioning of thelancet and the sensor, whereby a space for attachment of the sensor andthe lancet, and a space for moving the lancet can be secured.

Further, according to a fourth aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first tothird aspects, the sensor body is obtained by bonding two thin platestogether, and at least one of the two plates has a concave portion, withthe lancet being stored in a space which is formed by the concaveportion of the two plates bonded together.

Accordingly, a thinner lancet-integrated sensor can be provided.

Further, according to a fifth aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first tofourth aspects, when the lancet lances the skin to extract the bodilyfluid, the lancet projects its needle tip from an inside of the sensorbody in which the lancet is stored.

Accordingly, the needle tip of the lancet is housed in the sensor,whereby safety is further improved.

Further, according to a sixth aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first tofifth aspects, a cavity for collecting the bodily fluid is providedseparately from the space in the sensor body where the lancet is housed.

Accordingly, risk of damaging an inside of the cavity for collecting thebodily fluid by the lancet is avoided.

Further, according to a seventh aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first tosixth aspects, the space in the sensor body for housing the lancet alsoserves as a cavity for collecting the bodily fluid, and the bodily fluidis collected into the space for housing the lancet.

Accordingly, the bodily fluid is collected into the space where thelancet moves to lance the skin, whereby the size of thelancet-integrated sensor is further reduced.

Further, according to an eighth aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first tosixth aspects, an inlet of a cavity for collecting the bodily fluid isprovided at an end of the sensor from which the needle tip of the lancetis projected.

Accordingly, the bodily fluid is stored in the cavity at a front end ofthe sensor from which the needle tip protrudes, whereby time duringwhich collected bodily fluid is exposed to air is minimized.

Further, according to a ninth aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first toeighth aspects, the sensor body has, in a cavity, an electrode foroutputting an analysis result of characteristics of the bodily fluid.

Accordingly, the characteristics of the bodily fluid can be electricallymeasured.

Further, according to a tenth aspect of the present invention, in thelancet-integrated sensor defined in accordance with the ninth aspect, aconnection terminal to be connected with an external measuring device toelectrically measure the characteristics of the bodily fluid is providedat an end of the sensor body having the cavity.

Accordingly, the characteristics of the bodily fluid can be electricallymeasured by the external measuring device that is connected to thesensor.

Further, according to an eleventh aspect of the present invention, inthe lancet-integrated sensor defined in accordance with any of the firstto tenth aspects, a reagent that reacts with the collected bodily fluidis provided in the cavity.

Accordingly, the characteristics of the bodily fluid can be optically orelectrochemically measured by a chemical reaction between the reagentand the bodily fluid.

Further, according to a twelfth aspect of the present invention, in thelancet-integrated sensor defined in accordance with any of the first totenth aspects, an end of the lancet on a side opposite to the needle tipprojects from the sensor body, and a projecting end is engaged with adriving device of the external measuring device, whereby the lancet isdriven to perform a skin lancing operation.

Accordingly, the external driving device for driving the lancet can holda base end of the lancet, and drive the lancet in the longitudinaldirection of the sensor to make the lancet perform the lancingoperation.

Further, according to a thirteenth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with the twelfthaspect, a connector to be engaged with the driving device of theexternal measuring device is provided at the end of the lancet on theopposite side to the needle tip, and the connector is engaged with thedriving device, whereby the lancet performs the skin lancing operation.

Accordingly, the external driving device for driving the lancet caneasily hold the base end of the lancet to drive the lancet morereliably.

Further, according to a fourteenth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with the thirteenthaspect, the connector is made of a resin, and has a diameter larger thanthat of the lancet.

Accordingly, the external driving device for driving the lancet caneasily hold the base end of the lancet to drive the lancet morereliably.

Further, according to a fifteenth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with any of the firstto fourteenth aspects, a detachable protection cover is fitted to theneedle tip of the lancet, and the protection cover is removed during theskin lancing operation performed by the lancet.

Accordingly, injury by the needle tip of the lancet, and contaminationof the needle tip are avoided.

Further, according to a sixteenth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with the fifteenthaspect, the protection cover has a tube part for housing the needle tiptherein, and a wide grip part for facilitating removal of the protectioncover from the lancet, which grip part is provided on the needle tipside of the tube part.

Accordingly, removal of the protection cover that covers the needle tipof the lancet is facilitated.

Further, according to a seventeenth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with the fifteenthaspect, engagement of the lancet and the driving device, and attachmentof the sensor body integrated with the lancet to the measuring deviceare performed with holding of the grip part of the protection cover.

Accordingly, a user can attach the sensor and the lancet to themeasuring device by griping the protection cover, without holding thesensor and the lancet.

Further, according to an eighteenth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with the sixteenthaspect, a space in which the front end of the sensor body can be housedis formed in the tube part.

Accordingly, the sensor, which is fitted to the external measuringdevice and has finished measurement, can be set so that its front end ishoused in the protection cover. Then, this used sensor in this state canbe removed from the measuring device to be hygienically disposed of.

Further, according to a nineteenth aspect of the present invention, thelancet-integrated sensor defined in accordance with any of the first toeighteenth aspects is provided with a holder which covers a periphery ofthe integrated sensor body and lancet to hold these members.

Accordingly, a periphery of the integrated sensor and lancet is coveredwith the holder, and the user can easily handle the lancet-integratedsensor by griping the holder.

Further, according to a twentieth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with the nineteenthaspect, the holder is made of a transparent material.

Accordingly, the sensor and the lancet in the holder can be easilychecked, whereby handling is further facilitated.

Further, according to a twenty-first aspect of the present invention,the lancet-integrated sensor defined in accordance with any of the firstto twentieth aspects is of a disposable type, which will be discardedafter performing collection and analysis of bodily fluid one time.

Accordingly, not only the sensor but also the lancet are necessarilyrenewed for every measurement, such that these devices can behygienically managed.

Further, according to a twenty-second aspect of the present invention,there is provided a measuring device to which a lancet-integrated sensorthat is constituted by integrating a lancet for lancing skin of asubject to extract its bodily fluid, and a sensor body for analyzingthis extracted bodily fluid, are detachably attached, for measuringcharacteristics of the bodily fluid collected by the lancet-integratedsensor, and the measuring device includes a lancet driving device fordriving, after the lancet-integrated sensor is attached to the measuringdevice, the lancet so as to lance the skin.

Accordingly, a conventional lancet device is integrated with themeasuring device, whereby a lancing operation and measurement can beperformed by the measuring device alone without requiring a separatelancet device as is conventional. Further, since the lancet integratedwith the sensor is attached to the measuring device for everymeasurement, only the lancet driving device is to be added to theconventional measuring device and, therefore, the measuring device canbe realized at low cost.

Further, according to a twenty-third aspect of the present invention, inthe measuring device defined in accordance with the twenty-secondaspect, at least one end of the lancet-integrated sensor is projectedfrom the measuring device when attachment of the lancet-integratedsensor to the measuring device is completed.

Accordingly, a patient lances his/her fingertip with the lancet, anddrops bodily fluid onto the sensor, with an exposed end of thelancet-integrated sensor as a mark, whereby an operation is facilitated.Further, since an end of the lancet-integrated sensor is exposed, themeasuring device is prevented from being contaminated with the bodilyfluid or the like.

Further, according to a twenty-fourth aspect of the present invention,in the measuring device defined in accordance with the twenty-second ortwenty-third aspects, the lancet driving device drives the lancet of thelancet-integrated sensor so that a needle tip of the lancet is projectedfrom the sensor only when it lances the skin to collect the bodily fluidand, at all other times, the needle tip is housed in the sensor.

Accordingly, the needle tip of the lancet is housed in the sensor,whereby safety is further improved.

Further, according to a twenty-fifth aspect of the present invention,the measuring device defined in accordance with the twenty-fourth aspectis provided with a connector for maintaining electrical connection withan electrode terminal that is placed at an end of the sensor body of thelancet-integrated sensor, to measure characteristics of collected bodilyfluid by an internal electric circuit.

Accordingly, the characteristics of the bodily fluid can be electricallymeasured.

Further, according to a twenty-sixth aspect of the present invention, inthe measuring device defined in accordance with any of the twenty-secondto twenty-fifth aspects, the lancet driving device drives the lancetwhen it is engaged with an end of the lancet on a side opposite to theneedle tip, or when a grip part of a protection cover is gripped.

Accordingly, the external driving device for driving the lancet holdsthe end of the lancet, and drives the lancet in a longitudinal directionof the sensor to make the lancet perform a lancing operation. Further,when a holding part is provided on the end of the lancet, the drivingdevice can easily hold the lancet.

Further, according to a twenty-seventh aspect of the present invention,in the measuring device defined in accordance with the twenty-sixthaspect, the lancet driving device has a spring for applying a force tothe lancet in the longitudinal direction of the sensor, and the force ofthe spring is released by a press button that is provided on themeasuring device to project the lancet.

Accordingly, an end of the lancet or the holding part is engaged with anend of the spring, whereby elasticity of this coil spring is applied tothe lancet.

Further, according to a twenty-eighth aspect of the present invention,in the measuring device defined in accordance with any of thetwenty-first to twenty-seventh aspects, a lancet-integrated sensor asdefined in accordance with any of the fifteenth to eighteenth aspects isdetachably attached to the measuring device; attachment of thelancet-integrated sensor to the measuring device is performed with thetip of the lancet being covered with a protection cover, the sensor isheld by the connector of the measuring device, and an end of the lanceton the side opposite to the needle tip is supported by the lancetdriving device.

Accordingly, injury by the needle tip of the lancet, and contaminationof the needle tip are avoided.

Further, according to a twenty-ninth aspect of the present invention, inthe measuring device defined in accordance with any of the twenty-secondto twenty-eighth aspects, a lancet-integrated sensor as defined inaccordance with any of the nineteenth to twentieth aspects is detachablyattached to the measuring device, the sensor is held by the connector,and an end of the lancet on the side opposite to the needle tip or thegrip part of the protection cover is held by the driving device, inaccordance with operation of engaging the holder with the measuringdevice, so that the sensor and the lancet are attached to the measuringdevice in a state where the sensor and the lancet are being held by theholder.

Accordingly, a periphery of the integrated sensor and lancet is coveredwith the holder, and the user can easily handle the lancet-integratedsensor by gripping the holder.

Further, according to a thirtieth aspect of the present invention, inthe measuring device defined in accordance with any of the twenty-secondto twenty-ninth aspects, a lancet-integrated sensor which has been usedis ejected from the measuring device body without being touched byhands, by operating an operation button that is provided on themeasuring device body.

Accordingly, the user can remove a used lancet-integrated sensor fromthe measuring device without touching it so that his/her hands are notcontaminated, whereby infectious diseases or the like are avoided.

Further, according to a thirty-first aspect of the present invention, inthe measuring device defined in accordance with any of the twenty-secondto thirtieth aspects, an amount of projection of the needle tip of thelancet from the front end of the sensor is displayed on a display devicethat is provided on the measuring device body.

Accordingly, the user can certainly confirm the amount of projection ofthe needle tip of the lancet with the display device, whereby usabilityis improved.

Further, according to a thirty-second aspect of the present invention,there is provided a lancet-integrated sensor which is constituted byintegrating a lancet having a needle for lancing skin to collect bodilyfluid, and a sensor for analyzing this collected bodily fluid, wherein acavity for slidably housing a part of the lancet is formed in thesensor, and a force is applied to the lancet in a direction opposite toa direction along which the needle lances the skin, to house the needlein the sensor, whereby the lancet and the sensor are locked with eachother.

Accordingly, the lancet onto which bodily fluid sticks is locked in thesensor, whereby a user can safely remove the lancet-integrated sensorfrom the measuring device without touching the needle by mistake.

Further, according to a thirty-third aspect of the present invention, inthe lancet-integrated sensor defined in accordance with thethirty-second aspect: the lancet comprises anapproximately-rectangular-shaped plate member; the needle of the lancetis arranged in the vicinity of a center of one of shorter sides of theplate member so that it projects along a longitudinal direction of theplate member; the cavity is formed in a shape approximately identical toan outline shape that is obtained when the lancet is slid by apredetermined amount along the longitudinal direction thereof; andopenings for projecting the needle and another side of the lancet to theoutside of the sensor are formed at a front end and a rear end of thesensor, respectively.

Accordingly, the lancet onto which the bodily fluid sticks is locked inthe sensor, whereby the user can safely remove the lancet-integratedsensor from the measuring device without touching the needle tip bymistake.

Further, according to a thirty-fourth aspect of the present invention,in the lancet-integrated sensor defined in accordance with thethirty-second or thirty-third aspects: either a convex portion forlocking or a concave portion for locking is formed on the lancet, andeither a concave portion for locking or a convex portion for lockingwhich is engaged with the convex portion or the concave portion of thelancet is formed on the sensor; and the lancet and the sensor are lockedwith each other when the convex portion for locking and the concaveportion for locking are engaged with each other.

Accordingly, the lancet onto which the bodily fluid sticks is locked inthe sensor, whereby the user can safely remove the lancet-integratedsensor from the measuring device without touching the needle tip bymistake.

Further, according to a thirty-fifth aspect of the present invention, inthe lancet-integrated sensor defined in accordance with thethirty-fourth aspect: the lancet has two plate-shaped projections whichproject from two longer sides of the lancet in a width direction; theprojections have the concave portions for locking on their uppersurfaces; a cavity for slidably housing the lancet, which is formed inthe sensor, has two depressions for housing the two projections of thelancet, which depressions project in a width direction of the cavity;and the depressions have the concave portions for locking at theirceilings.

Accordingly, the lancet onto which the bodily fluid sticks is locked inthe sensor, whereby the user can safely remove the lancet-integratedsensor from the measuring device without touching the needle tip bymistake.

Further, according to a thirty-sixth aspect of the present invention,the measuring device for performing measurement using alancet-integrated sensor, which is defined in accordance with thethirty-third aspect, comprises: a guide member for guiding thelancet-integrated sensor that is inserted from an opening provided on aside surface of the measuring device, thereby restricting a directionalong which the lancet-integrated sensor travels in the measuringdevice; a lancet pressing member which is pushed by a spring member inthe measuring device in a direction opposite to the direction alongwhich the lancet-integrated sensor is inserted, and is engaged withanother shorter side of the lancet that is guided toward the inside ofthe measuring device by the guide member, thereby pressing the lancettoward the opening; a locking member for fixing the lancet pressingmember at a predetermined position in the measuring device when thelancet-integrated sensor is inserted deeper into the measuring device;an unlocking member for releasing fixation of the lancet pressing memberby the locking member, with manual operation; and an ejection member forapplying a force to the sensor of the lancet-integrated sensor to pushthe sensor toward an opening side, with manual operation, which ejectionmember is provided between the lancet pressing member and the guidemember.

Accordingly, it is possible to realize a measuring device which canperform measurement using a lancet-integrated sensor that can be safelyremoved from the measuring device because the lancet to which the bodilyfluid sticks is locked in the sensor to prevent hands of the user fromtouching the needle tip by mistake and, after measurement, thelancet-integrated sensor can be safely removed from the measuring devicewith the needle tip being housed in the sensor.

Further, according to a thirty-seventh aspect of the present invention,in the measuring device for a lancet-integrated sensor which is definedin accordance with the thirty-sixth aspect, the ejection member slidesan operation lever that is exposed at a main surface of the measuringdevice, toward the opening side, whereby a pressing member that isunited with the operation lever presses the vicinity of both sides of anend of the lancet-integrated sensor, which end is opposite to the sidewhere the lancet lances the skin, thereby ejecting the lancet-integratedsensor.

Accordingly, it is possible to realize a measuring device which canperform measurement using a lancet-integrated sensor that can be safelyremoved from the measuring device because the lancet to which the bodilyfluid sticks is locked in the sensor to prevent hands of the user fromtouching the needle tip by mistake and, after the measurement, thelancet-integrated sensor can be safely removed from the measuring devicewith the needle tip being housed in the sensor.

Further, according to a thirty-eighth aspect of the present invention,there is provided a measuring device for performing measurement using alancet-integrated sensor which is constituted by integrating a lancetfor lancing skin to collect bodily fluid, and a sensor for analyzingthis collected bodily fluid, wherein: the measuring device for thelancet-integrated sensor has an opening on a side surface; the measuringdevice has a cavity in which the lancet-integrated sensor can be housed,which cavity is formed corresponding to the opening; a holder attachmentpart is formed on a side of the measuring device having the opening,which holder attachment part detachably attaches a holder body in whichthe lancet-integrated sensor can pass through, to the measuring device;and the holder body guides the lancet-integrated sensor when thelancet-integrated sensor is housed in the cavity and, after it is housedin the cavity, the holder body holds a portion of the lancet-integratedsensor in the vicinity of the end where the lancet lances the skin.

Accordingly, the holder body is constituted to be detachable from themeasuring device so that replacement or washing of the holder body iseasily performed, and the measuring device can be used not only by aspecific user but also by other persons, whereby the measuring devicefor the lancet-integrated sensor can be safely and hygienically used.

Further, according to a thirty-ninth aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the thirty-eighth aspect: engagement portions of theholder and the holder attachment part have asymmetrical shapes in avertical direction or in a horizontal direction; and attachment of theholder to the holder attachment part is possible only when the verticaldirection of the holder with respect to the holder attachment part is apredetermined direction.

Accordingly, the holder body can always be inserted into the measuringdevice in a normal direction, and the lancet-integrated sensor isprevented from being inserted upside down into the measuring device.

Further, according to a fortieth aspect of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inaccordance with the thirty-eighth aspect, the opening of the holderattachment part into which the holder body is inserted has a shape of anapproximate rectangle that is side-to-side long, with portionscorresponding to corners of the rectangle being rounded, and the openinghas smaller openings overhanging in a width direction in the vicinitiesof centers of two sides in a longitudinal direction.

Accordingly, the opening of the holder attachment part becomesasymmetrical in the longitudinal direction and in the width direction,whereby the holder is prevented from being inserted in a wrongdirection.

Further, according to a forty-first aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the fortieth aspect: the holder body has hinge-shapedstoppers; inner sides of the hinge-shaped stoppers are fixed to theholder body; and outer sides of the hinge-shaped stoppers are engagedwith the engagement portions of the holder attachment part.

Accordingly, the holder body can always be inserted into the measuringdevice in the normal direction, and the lancet-integrated sensor isprevented from being inserted upside down into the measuring device.

Further, according to a forty-second aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the fortieth aspect: the holder body has a peripheraledge part that extends along a surface of the opening at a periphery ofthe opening excluding the smaller openings, on the side where the holderbody is attached to the measuring device; the hinge-shaped stoppers areprovided in portions of the peripheral edge part corresponding to thesmaller openings; and the hinge-shaped stoppers are obtained byextending band-shaped elastic members in the direction along which thelancet-integrated sensor is impacted into the holder body, and bendingthe elastic members outward by 180°.

Accordingly, the holder body is attached to the measuring device withstability, by an extending force due to the elasticity of the stopper.

Further, according to a forty-third aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the forty-second aspect, each of the hinge-shapedstoppers has a clip member at a front end of the band-shaped elasticmember, which clip member is thicker than the elastic member, andperforms positioning when the holder body is latched in the opening.

Accordingly, a front end of each stopper is engaged with an inside ofthe smaller opening of the measuring device so as to preventdisconnection of the stopper from the smaller opening, whereby theholder body is attached to the measuring device with stability.

Further, according to a forty-fourth aspect of the present invention,there is provided a biosensor cartridge for housing plural biosensors,each having a reagent layer for detecting a specific component in bodilyfluid of a subject, and an electrode for removing an electric signalindicating that the reagent layer detects the specific component,wherein a cartridge body has, at an end of its upper surface, a hingefor rotatably fixing a lid that covers the cartridge. The cartridge bodyhas plural slits for perpendicularly supporting respective biosensor,and the plural slits are formed in parallel with each other, from anupper surface toward a lower surface of the cartridge body, at regularintervals which allow an insertion slot of a measuring device forperforming measurement using a target biosensor to be inserted withouttouching biosensors adjacent the target biosensor.

Accordingly, a user can attach a sensor to the measuring device by onlyopening the lid and pressing the sensor insertion slot of the measuringdevice onto the sensor. Therefore, troublesome preparation formeasurement, i.e., holding the sensor with hands to insert it into themeasuring device for every measurement, is saved, resulting in improvedusability.

Further, according to a forty-fifth aspect of the present invention, inthe biosensor cartridge defined in accordance with the forty-fourthaspect, the cartridge body to which the lid is attached is a rectangularparallelepiped in shape.

Accordingly, the user can attach the sensor to the measuring device byonly opening the lid and pressing the sensor insertion slot of themeasuring device onto any of the sensors which are supported at regularintervals by the rectangular parallelepiped cartridge body. Therefore,troublesome preparation for measurement, i.e., holding the sensor withhands to insert it into the measuring device for every measurement, issaved, resulting in improved usability.

Further, according to a forty-sixth aspect of the present invention, inthe biosensor cartridge defined in accordance with the forty-fifthaspect, the lid is a hollow rectangular parallelepiped in shape, and hasan opening at a portion opposed to an upper surface of the cartridgebody.

Accordingly, the user can attach the sensor to the measuring device byonly opening the hollow and rectangular parallelepiped lid, and pressingthe sensor insertion slot of the measuring device onto any of thesensors which are supported at regular intervals by the rectangularparallelepiped cartridge body. Therefore, troublesome preparation formeasurement, i.e., holding the sensor with hands to insert it into themeasuring device for every measurement, is saved, resulting in improvedusability.

Further, according to a forty-seventh aspect of the present invention,in the biosensor cartridge defined in accordance with the forty-fourthaspect, a bottom of each slit has a shape that conforms to a shape of afront end of the biosensor.

Accordingly, the bottom of each slit of the cartridge body conforms tothe shape of the front end of the biosensor so that no stress is appliedto a specific portion of the front end of the biosensor, whereby thebiosensor can be supported with reliability.

Further, according to a forty-eighth aspect of the present invention, inthe biosensor cartridge defined in accordance with the forty-seventhaspect, the front end of the biosensor is semi-circular in shape.

Accordingly, the bottom of each slit of the cartridge body conforms tothe semi-circular shape of the front end of the biosensor so that nostress is applied to a specific portion of the front end of thebiosensor, whereby the biosensor can be supported with reliability.

Further, according to a forty-ninth aspect of the present invention, inthe biosensor cartridge defined in accordance with the forty-fourthaspect: the hinge is constituted by a pair of bearings each having aside-to-side long bearing hole that projects outward along alongitudinal direction of the cartridge body from an end of the uppersurface of the cartridge body, and a pair of axial projections which areprovided at an end of the lid, and serve as fulcra when beingsmooth-movably engaged with the bearings to rotate the lid; a peripheraledge part is formed at a periphery of the upper surface of the cartridgebody, which part extends in a direction perpendicular to side walls ofthe cartridge body, and has plural notches; reverse-L-shaped projectionsare formed on the same plane as the side walls of the lid, in positionscorresponding to the notches of the peripheral edge part, at a peripheryof the opening of the lid; and a sealing member having elasticity isformed on an upper surface of the peripheral edge part.

Accordingly, after the lid is closed, the lid is slid in the horizontaldirection so that the reverse-L-shaped projections on the lid areengaged with the notches of the peripheral edge part of the cartridgebody, whereby the sealing member having elasticity adheres closely tothe edge of the opening of the lid and to the peripheral edge part ofthe cartridge body, and hermeticity in the cartridge is increased,thereby preventing the sensor from being contaminated with moisture.

Further, according to a fiftieth aspect of the present invention, thereis provided a biosensor cartridge for housing plural lancet-integratedbiosensors, each being constituted by integrating a biosensor having areagent layer for detecting a specific component in bodily fluid of asubject, and an electrode for removing an electric signal indicatingthat the reagent layer detects the specific component, with a lancet forcollecting the bodily fluid of the subject, wherein: the cartridge bodyhas, at an end of its upper surface, a hinge for rotatably fixing a lidthat covers the cartridge body; the cartridge body has plural groovesfor perpendicularly supporting the lancet-integrated biosensors; and theplural grooves are formed in parallel with each other, from an uppersurface toward a lower surface of the cartridge body, at regularintervals which allow an insertion slot of a measuring device forperforming measurement using a target biosensor to be inserted withouttouching biosensors adjacent the target biosensor.

Accordingly, a user can attach the lancet-integrated sensor to themeasuring device by only opening the lid and pressing the sensorinsertion slot of the measuring device onto the sensor. Therefore,troublesome preparation for measurement, i.e., holding thelancet-integrated sensor with hands to insert it into the measuringdevice for every measurement, is saved, resulting in improved usability.

Further, according to a fifty-first aspect of the present invention, inthe biosensor cartridge defined in the fiftieth aspect, thelancet-integrated biosensor includes: an approximately-square-shaped andnarrow protector for protecting the lancet that projects from thelancet-integrated biosensor in its unused state; a sensor body in whichthe lancet is smooth-movably housed, the sensor body being approximatelyrectangular in shape, has a front end being semi-circular in shape, andis a little wider than the protector; and a connector which is providedon the lancet, protrudes backward from the sensor body, and has a widthapproximately equal to a width of the sensor body. Each of the pluralgrooves comprises a narrow first groove which is provided at a lowestsurface side of the cartridge body, and conforms to the shape of theprotector; a second groove which is wider than the first groove, isprovided above the first groove, and conforms to the shape of a portionof the sensor body; and a third groove which is wider than the secondgroove, is provided above the second groove, and conforms to the shapeof the insertion slot part of the measuring device into which the sensorbody is inserted.

Accordingly, the lancet-integrated sensors each having a complicatedshape can be supported at regular intervals, and a user can attach thelancet-integrated sensor to the measuring device by only pressing thesensor insertion slot of the measuring device onto the sensor.Therefore, troublesome preparation for measurement, i.e., holding thesensor with hands to insert it into the measuring device for everymeasurement, is saved, resulting in improved usability.

Further, according to a fifty-second aspect of the present invention, inthe biosensor cartridge defined in accordance with the fifty-firstaspect: the insertion slot stores the sensor body into a cavity whichpenetrates a pillar-shaped projection that projects from a side surfaceof the measuring device; and the connector is stored in the cavity thatextends into the measuring device.

Accordingly, the user can attach the lancet-integrated sensor having acomplicated rear-end shape to the measuring device by only pressing thesensor insertion slot of the measuring device onto the sensor.Therefore, troublesome preparation for measurement, i.e., holding thesensor with hands to insert it into the measuring device for everymeasurement, is saved, resulting in improved usability.

Further, according to a fifty-third aspect of the present invention,there is provided a measuring device for performing measurement using alancet-integrated sensor that is attached thereto, with thelancet-integrated sensor being constituted by integrating a lancet forlancing skin to collect bodily fluid, and a sensor for analyzingextracted bodily fluid. The measuring device includes a drive device fordriving the lancet in a direction in which the lancet lances the skin,along a longitudinal direction of the sensor, from a standby position ofthe lancet. After the drive device has driven the lancet in thedirection in which the lancet lances the skin, the drive device candrive the lancet back to the standby position while maintaining a statewhere the lancet-integrated sensor is attached to the measuring device.

Accordingly, even when the lancet fails to lance the skin during aprocess of collecting bodily fluid, or measurement cannot be performeddue to some problem, re-preparation for measurement can be easilyperformed, whereby usability of the measuring device for thelancet-integrated sensor is further improved.

Further, according to a fifty-fourth aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the fifty-third aspect, the drive device has a shaft towhich a connector receiver is fixed at an end on a side where the lancetlances the skin, which connector receiver receives an end of the lanceton the side opposite to the side where the lancet lances the skin. Apull stick for driving the lancet back in a direction opposite to thedirection in which the lancet lances the skin is disposed on an end ofthe shaft on the side opposite to the side where the lancet lances theskin, and the connector receiver is provided with a claw portion whichis unlocked by pressing an operation button to start operation of thedrive device, and stops motion of the connector receiver against a forceapplied by a spring that is provided on the shaft to move the connectorreceiver in the direction in which the lancet lances the skin.

Accordingly, even when the lancet fails to lance the skin during aprocess of collecting bodily fluid, or measurement cannot be performeddue to some problem, re-preparation for measurement can be easilyperformed by operating the pull stick, whereby usability of themeasuring device for the lancet-integrated sensor is further improved.

Further, according to a fifty-fifth aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the fifty-fourth aspect: the measuring device has, inits internal cavity, a support member for slidably supporting the shaftin the vicinity of its center; and the spring is a coil spring which isplaced between the support member of the shaft and the connectorreceiver.

Accordingly, the shaft is supported in the measuring device, and thecoil spring which is placed between the support member and the connectorreceiver supplies a force for driving the lancet.

Further, according to a fifty-sixth aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the fifty-fourth aspect: the pull stick has an openingwhich is formed at an end of the side where the lancet lances the skin;an end of the shaft on the side opposite to the side where the lancetlances the skin is slidably housed in the pull stick through theopening; and the end of the shaft on the side opposite to the side wherethe lancet lances the skin has a slip-out prevention member forpreventing the end of the shaft from slipping out of the pull sticktoward the side where the lancet lances the skin.

Accordingly, the shaft can be drawn out in the lancet projectingdirection and in the opposite direction by pulling the pull stick.

Further, according to a fifty-seventh aspect of the present invention,in the measuring device for a lancet-integrated sensor which is definedin accordance with the fifty-fourth aspect, the driving device isprovided with a lancet projection amount adjuster for adjusting anamount of projection of the needle of the lancet that lances the skin,which driving device is placed between the measuring device and the pullstick.

Accordingly, the amount of projection of the needle tip of the lancet isadjustable, whereby an amount of bodily fluid oozing out of the skin ofthe subject can be adjusted, or pain by being lanced with the lancet canbe reduced.

Further, according to a fifty-eighth aspect of the present invention, inthe measuring device for a lancet-integrated sensor which is defined inaccordance with the fifty-seventh aspect: the pull stick isapproximately cylindrical in shape, and an end of the pull stick on aside opposite to the side where the lancet lances the skin has a handlepart having a portion of a diameter larger than a diameter of thecylindrical part; the lancet projection amount adjuster is approximatelycylindrical in shape, and an end of the adjuster on the side opposite tothe side where the lancet lances the skin has an opening having adiameter equal to the diameter of the cylindrical part of the pullstick; and the cylindrical part is slidably housed through the opening,and the cylindrical part is screwed into a screw hole that is formed ona side surface of the measuring device on the side opposite to the sidewhere the lancet lances the skin, toward an inside of the measuringdevice, whereby the cylindrical part rotates in a screwing direction orin an opposite direction to adjust the amount of projection of thelancet.

Accordingly, the amount of projection of the needle tip of the lancet isadjustable, whereby an amount of the bodily fluid oozing out of the skinof the subject can be adjusted, or pain by being lanced with the lancetcan be reduced.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1( a) and 1(b) are diagrams illustrating a lancet-integratedsensor according to a first embodiment of the present invention, whereinFIG. 1( a) is a perspective view of the lancet-integrated sensor in itsentirety, and FIG. 1( b) is an exploded perspective view thereof.

FIGS. 2( a)-2(d) are plan views for explaining operation of thelancet-integrated sensor, wherein FIG. 2( a) shows a state where aneedle tip, which is covered with a protection cover, protrudes from thesensor, FIG. 2( b) shows a state where the needle tip, which is coveredwith the protection cover, is housed in the sensor, FIG. 2( c) shows astate where the needle tip, from which the protection cover is removed,protrudes from the sensor, and FIG. 2( d) shows a state where the needletip, from which the protection cover is removed, is housed in thesensor.

FIGS. 3( a) and 3(b) are perspective views of a measuring device to becombined with the lancet-integrated sensor according to the firstembodiment of the invention, wherein FIG. 3( a) shows an upper surfaceof the measuring device, and FIG. 3( b) shows a lower surface thereof.

FIGS. 4( a) and 4(b) are diagrams for explaining an internal structureof the measuring device, wherein FIG. 4( a) is an exploded perspectiveview of a lower half side of the measuring device, and FIG. 4( b) is across-sectional view of a side surface thereof.

FIGS. 5( a)-5(c) are diagrams for explaining an operation for attachingthe lancet-integrated sensor to the measuring device, wherein FIG. 5( a)is a sectional side elevation view at a starting of attachment, FIG. 5(b) is a sectional side elevational view at completion of the attachment,and FIG. 5( c) is a sectional view in the vicinity an operation button.

FIGS. 6( a) and 6(b) are diagrams illustrating a protection cover of thelancet-integrated sensor according to the first embodiment of theinvention, wherein FIG. 6( a) shows a state where the protection coveris fitted when the needle tip protrudes, and FIG. 6( b) shows a statewhere the protection cover is fitted to a front end of the sensor whenthe needle tip is housed.

FIG. 7 is a perspective view of a measuring device to be combined withthe lancet-integrated sensor according to the first embodiment of theinvention.

FIGS. 8( a) and 8(b) are diagrams illustrating a lancet-integratedsensor according to a second embodiment of the invention, wherein FIG.8( a) shows a perspective view of the lancet-integrated sensor in itsentirety, and FIG. 8( b) is an exploded perspective view thereof.

FIGS. 9( a) and 9(b) are diagrams illustrating the lancet-integratedsensor according to the second embodiment of the invention and ameasuring device for the lancet-integrated sensor, wherein FIG. 9( a) isa perspective view of the measuring device in a state where the sensoris attached thereto, and FIG. 9( b) is a cross-sectional view of themeasuring device in a state where the sensor is attached thereto.

FIG. 10 is a diagram for explaining engagement of a fine concave portionprovided in the lancet with a fine convex portion provided in thesensor.

FIGS. 11( a) and 11(b) are diagrams illustrating an appearance of ameasuring device for a lancet-integrated sensor according to a thirdembodiment of the invention, wherein FIG. 11( a) shows a state where aholder is attached, and FIG. 11( b) shows a state where the holder isremoved.

FIGS. 12( a)-12(c) are diagrams illustrating an appearance of the holderof the measuring device for a lancet-integrated sensor according to athird embodiment of the invention, wherein FIG. 12( a) is an elevationalview in a state where the holder is attached to the measuring device,FIG. 12( b) is a cross-sectional view when the holder attached to themeasuring device is viewed from above, and FIG. 12( c) is across-sectional view when the holder to be removed from the measuringdevice is viewed from above.

FIGS. 13( a) and 13(b) are diagrams illustrating an internal structureof a measuring device which uses a lancet-integrated sensor according tothe third embodiment of the invention, and another construction of alancet-integrated sensor, wherein FIG. 13( a) is a cross-sectional viewof the measuring device in a state where the holder is attached, andFIG. 13( b) is a partially cutaway cross-sectional view of the measuringdevice in a state where the holder is attached.

FIG. 14 is a diagram illustrating an appearance of a measuring devicewhich uses a lancet-integrated sensor according to a fourth embodimentof the invention.

FIG. 15 is a cross-sectional view illustrating an internal structure ofthe measuring device according to the fourth embodiment of theinvention.

FIG. 16 is a cross-sectional view illustrating a biosensor cartridgeaccording to a fifth embodiment of the invention.

FIGS. 17( a) and 17(b) are diagrams illustrating a state where a sensorstored in the biosensor cartridge according to the fifth embodiment ofthe invention is inserted into a measuring device, wherein FIG. 17( a)shows a state where the sensor is inserted, and FIG. 17( b) shows astate before the sensor is inserted.

FIGS. 18( a)-18(c) are diagrams illustrating a biosensor cartridgeaccording to a first modification of the fifth embodiment of theinvention, wherein FIG. 18( a) is a perspective view illustrating astate where a lid is opened, FIG. 18( b) is a side view illustrating astate where the lid is closed, and FIG. 18( c) is a cross-sectional viewillustrating a state where the lid is closed.

FIG. 19 is a diagram illustrating a biosensor cartridge according to asecond modification of the fifth embodiment of the invention.

FIGS. 20( a) and 20(b) are diagrams for explaining attachment of alancet-integrated sensor to a measuring device in the biosensorcartridge according to the second modification of the fifth embodimentof the invention, wherein FIG. 20( a) is a diagram illustrating a statewhere the sensor is attached, and FIG. 20( b) is a diagram illustratinga state before the sensor is attached.

FIG. 21 is a perspective view illustrating an example of a conventionalmeasuring device for a biosensor.

FIGS. 22( a) and 22(b) are diagrams illustrating a conventional lancetdevice, wherein FIG. 22( a) is a perspective view thereof, and FIG. 22(b) is a perspective view thereof in a state where a part of the lancetdevice is seen through.

FIGS. 23( a) and 23(b) are diagrams illustrating a conventional mannerof housing biosensors, wherein FIG. 23( a) shows a state where abiosensor is wrapped with a wrapper, and FIG. 23( b) shows a state whereplural biosensors are stored in a plastic container.

FIG. 24 is a diagram illustrating a state where a biosensor is insertedinto a measuring device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiment 1

Hereinafter, a first embodiment of the present invention will bespecifically described taking, as an example, a blood sugar sensor forelectrochemically measuring blood sugar, with reference to the drawings.

The first embodiment relates to a lancet-integrated sensor in which alancet and a sensor are integrated to facilitate management andcarrying, and a measuring device for driving the lancet-integratedsensor, and performing measurement using the sensor.

That is, in the lancet-integrated sensor according to the firstembodiment, a long and narrow strip-shaped sensor and a lancet areintegrated with each other and, more specifically, the lancet ishorizontally movable along a longitudinal direction of the sensor.

The measuring device, to which the lancet-integrated sensor is fitted,is provided with a lancet driving function of a conventional lancetdevice. That is, the measuring device is provided with a driving memberfor driving the lancet of the lancet-integrated sensor that is fittedthereto.

In this construction, a patient sets a new lancet-integrated sensor ontothe measuring device every time he/she performs measurement. Then, thepatient grips the measuring device, and turns on the lancet drivingmember to lance his/her fingertip with the lancet. Subsequently, thepatient drops blood onto the sensor to measure blood sugar or the like.

Hereinafter, the lancet-integrated sensor and the measuring device willbe described more specifically.

FIGS. 1( a) and 1(b) are a perspective view and an exploded perspectiveview of a lancet-integrated sensor according to the first embodiment ofthe invention, respectively. With reference to FIG. 1( a), numeral 10denotes a lancet-integrated sensor, wherein numeral 1 denotes a long andnarrow strip-shaped sensor, and numeral 2 denotes a lancet, a greaterpart of which is housed in a hollow (space) 1 a in the sensor 1, and thelancet 2 is supported by the sensor (sensor body) 1 so as to be slidablein a longitudinal direction of the sensor 1.

Reference numeral 3 denotes a protection cover into which a needle tipof the lancet 2 is pressed, thereby protecting the needle tip. Thiscover 3 is removed during measurement. Reference numeral 4 denoteselectrode terminals for making electrical connection with a measuringdevice which is later described. Reference numeral 5 denotes a cavityprovided at a semi-circular front end of the sensor 1.

As shown in FIG. 1( b), construction of the sensor 1 is obtained bybonding a cover (plate) 6 to a substrate (plate) 7, which are made of aresin such as polyethylene terephthalate. Further, the lancet 2comprises a metal needle 2 a, and a connector (end portion) 2 b whichhas the needle 2 a at its front end, and holds the needle 2 a. A rearend portion of the strip-shaped connector 2 b projects from a rear endof the sensor 1 to be engaged with the driving member of the measuringdevice which is described later.

At a lower surface of the cover 6, concave portions which conform to ashape of the lancet 2 are provided. More specifically, there areprovided a groove (concave portion) 6 a which conforms to an outline ofthe connector 2 b so that the connector 2 b is slidably housed thereinalong its longitudinal direction, and a long and narrow groove (concaveportion) 6 b in which the needle 2 a is housed. The groove 6 b in whichthe needle 2 a is housed is extended to the front end of the sensor 1.Further, a pair of electrodes 8 leading to the electrode terminals 4 areformed on a surface of the substrate 7, and a reagent layer (not shown)is formed on a surface of the electrodes 8.

In this way, the lancet-integrated sensor is obtained by bonding thecover 6 and the substrate 7 together, with the lancet 2 being placedtherebetween. Accordingly, the cavity 5 also serves as the long andnarrow groove 6 b into which the needle 2 a is housed. Further, portionsof the electrodes 8 and the reagent layer are exposed in the cavity 5.

As described above, the lancet 2 is movable along the longitudinaldirection of the sensor 1, and its motion will be described hereinafterwith reference to a plan view shown in FIGS. 2( a)-2(d).

FIG. 2( a) shows a state where a position of the lancet 2 is closest tothe front end of the sensor 1. That is, each of fine projections 2 c,which are formed so as to project from the connector 2 b in a directionperpendicular to a longer side of the connector 2 b within the sameplane as a main surface of the connector 2 b, abuts a side wall 60 b atan end of a wide concave groove (concave portion) 60 a on a topmost sideof the sensor 1, which groove 60 a is formed in the cover 6. In thisstate, a longest portion of the needle 2 a of the lancet 2 projects fromthe front end of the sensor 1. FIG. 2( b) shows a state where each ofthe fine projections 2 c of the connector 2 b abuts a side wall 60 c atan end of the concave groove 60 a on a rearmost side of the sensor 1. Inthis state, the needle of the lancet 2 is completely housed in thesensor 1.

As shown in FIGS. 2( a) and 2(b), a shape of the groove 60 a is curvedsuch that, at an end where the fine projection 2 c is positioned, awidth of the groove 60 a is a little narrower than a width of theconnector 2 b including the fine projection 2 c. Accordingly, at the endof the concave groove 60 a, the connector 2 b is latched by the sensor 1due to mutual pressing or friction.

The construction of the lancet-integrated sensor is as described above,and the protection cover 3 is removed for measurement, and a fingertipor the like is lanced with the tip of the needle 2 a of the lancet 2which projects from an opening of the cavity 5, as shown in FIG. 2( c).When blood is dropped onto the sensor 1 and sucked into the cavity 5 tomeasure blood sugar as shown in FIG. 2( d), the needle tip of the lancet2 is positioned in the groove 6 a which is apart from the cavity 5 sothat the needle does not contact the blood sucked into the cavity 5.

Measuring Device

Next, an example of a measuring device to be connected with theabove-described lancet-integrated sensor will be described withreference to the drawings.

FIGS. 3( a) and 3(b) are perspective views of a measuring device 11 towhich a lancet-integrated sensor is fitted, and FIG. 3( a) mainly showsits upper surface while FIG. 3( b) mainly shows its lower surface.Reference numeral 12 denotes a display (display device) for displaying aresult of measurement and the like, and numeral 13 denotes a slot intowhich the lancet-integrated sensor is inserted. Reference numeral 14denotes a push button (unlocking member) for driving the lancet that isfitted to the measuring device 11 such that the lancet forcibly projectsto lance a fingertip or the like. Further, reference numeral 15 denotesa slide button (ejection member, operation button) for ejecting a usedlancet-integrated sensor from the measuring device 11. Further,reference numeral 16 denotes an adjustment button (lancet projectionamount adjuster) for adjusting an amount of projection of the needle tipof the lancet.

FIG. 4( a) is a perspective view of the measuring device 11 in a statewhere an upper portion of a package case is removed to show an internalstructure of the measuring device 11, and FIG. 4( a) specifically showsa connection terminal to be electrically connected with the sensor, andthe driving member to be engaged with the connector of the lancet.Further, FIG. 4( b) is a side view of the measuring device.

Reference numeral 17 denotes a pair of guides having connectionterminals to be electrically connected with the electrode terminals ofthe sensor. The guides 17 are planted on substrate 11 a at a bottom ofthe package case by resin molding so as to have approximately-L-shapedcross sections, and connection terminals are formed on ceilings of theguides 17. Further, at an end of each guide 17, which is opposite to aconnector receiver 19, a termination member 17 a is planted to make adead-end, excluding a space between the guides 17. When fitting thelancet-integrated sensor to the measuring device, the sensor 10 isguided by the guides 17 to be set.

Reference numeral 18 denotes a coil spring (lancet pushing member) fordriving the lancet 2, and numeral 19 denotes the connect receiver(lancet pushing member) which is engaged with the connector 2 b of thelancet 2. The connector receiver 19 is slidably supported by a pair ofapproximately-inverse-L-shaped supporting members 24 which are plantedon the substrate 11 a, and an end of the coil spring 18 is fixed onto aside of the connector receiver 19, which is opposite to a side that isengaged with the sensor 10. Another end of the coil spring 18 issupported by a spring stopper (lancet pushing member) 23. When thelancet 2 is engaged with the connector receiver 19 and the lancet 2 ispushed into the measuring device 11, the coil spring 18 is compressed,whereby a force for driving the lancet 2 is applied to the coil spring18.

Reference numeral 20 denotes a driving lever having a tapered projection20 a which is engaged with a tapered projection 11 c that is positionedin front of the push button 14. When the lancet 2 is set up to apredetermined position, the driving lever 20 latches the connectorreceiver 19 to hold a driving force. This latching is canceled bypushing the push button 14, and the lancet 2 is driven by a pressingforce from the spring 18.

Reference numeral 21 denotes a torsion spring for restricting a positionof the connector receiver 19, and the torsion spring 21 is fixed by ashaft member 25 that is planted in the vicinity of a side surfaceparallel with an insertion path of the sensor 10. The torsion spring 21pushes the connector receiver 19 that is not latched by the drivinglever 20, in a direction against elasticity of the coil spring 18. Thetorsion spring 21 restricts a position of the connector receiver 19, inbalance with the elasticity of the coil spring 18, so that the needletip of the lancet 2 is positioned apart from the cavity 5 to prevent theneedle tip from contacting blood drawn into the cavity 5.

Reference numeral 22 denotes an ejection lever which is united with theslide button 15, and the ejection lever 22 pushes a rear end of thesensor 1 to eject the sensor 1 from the measuring device when the slidebutton 15 is operated in a direction indicated by arrow a.

Measuring Operation

Hereinafter, a description will be given of a series of measuringoperations, with respect to the lancet-integrated sensor and themeasuring device, which are constructed as described above.

Initially, an operation for fitting the lancet-integrated sensor to themeasuring device will be described. The lancet-integrated sensor is in astate shown in FIG. 2( a) when it is not used. That is, the needle tipof the lancet 2 projects from the sensor 1, and is covered with theprotection cover 3. A patient grips a wide grip part 3 a of theprotection cover 3, and inserts the lancet 2, from a connector 2 b side,into the insertion slot 13 of the measuring device 11.

The patient further pushes the grip part 3 a of the protection cover 3to insert the sensor 1 and the lancet 2 deeper into the measuring device11. Thereby, as shown in FIG. 5( a), the sensor 1 is guided by the guide17 to advance into a case 11 b. As the sensor 1 continues to advanceinto the case, a shorter side of the sensor 1, which is opposite to thesemi-circular side thereof, touches the termination member 17 a of theguide 17 to be set at a fixed position where advance of the sensor 1into the case 11 b is restricted, whereby the electrode terminals 4 ofthe sensor 1 are connected to the connection terminals (not shown) ofthe measuring device 11. In order to make FIG. 5( a) easy to see, onlythe sensor 1 of the lancet-integrated sensor is shown, and a partcorresponding to the lancet 2 is omitted.

Although advance of the sensor 1 is stopped at this point of time, sincemotion of the lancet 2 is not restricted by the termination members 17 aof the guides 17 as shown in FIG. 5( c), the lancet 2 can be inserteddeeper into the case 11 b. That is, by a pressing force of theprotection cover 3, the engagement of the fine projections 2 c with theconcave groove 60 a is released at the position shown in FIG. 2( a).Then, as shown in FIG. 2( b), the tube 3 b of the protection cover 3,which protects the needle 2 a, is pushed into the sensor 1, and a sideof the grip part 3 a of the protection cover 3 touches the front end ofthe sensor 1.

When the patient pushes the protection cover 3 deeper than the stateshown in FIG. 5( a), the connector 2 b of the lancet 2 is engaged withconcave portion 19 a of the connector receiver 19 and, as shown in FIG.5( b), the coil spring 18 is compressed, whereby tapered projection 20 aof the driving lever 20 of the connector receiver 19 is latched bytapered projection 11 c in front of the push button 14 to completefitting of the sensor 10.

Next, a blood collecting operation and a blood dropping operation willbe described. FIG. 3( a) shows a state where fitting of thelancet-integrated sensor to the measuring device is completed. Thepatient holds the measuring device 11, and lightly pushes the front endof the sensor 10 against a portion of his/her body from which blood isto be extracted, such as a fingertip.

When the patient pushes the push button 14, the lancet 2 is driven, andthe needle tip forcibly projects from the front end of the sensor 10 tolance skin of the patient. At this time, an amount of projection of theneedle tip from the sensor is variable by sliding the adjustment button16 in a horizontal direction. To be specific, the torsion spring 21 ismoved in the horizontal direction in the measuring device 11 by slidingthe adjustment button 16 in the horizontal direction, thereby to adjusta spring force. Alternatively, a distance between the connector receiver19 that is engaged with the push button 14, and the spring stopper 23 isincreased or reduced by driving a mechanism (not shown) for convertingmotion of the adjustment button 16 in the horizontal direction into ato-and-fro motion of the spring stopper 23 along a driving direction ofthe lancet 2. The amount of projection can be displayed on the displayunit 12 by converting an amount of sliding of the adjustment button 16to an amount of projection using a CPU or the like of the measuringdevice.

The patient drops a small amount of blood that is oozing from a lancedfingertip, for example, onto the front end of the sensor 10, and thisdropped blood is drawn into the cavity 5 by capillary phenomenon. Themeasuring device 11 measures blood sugar with an internal electroniccircuit, and displays a result of this measurement on the display unit12. When the result of measurement is displayed to end measurement, thepatient slides the slide button 15 in a direction toward which thelancet 2 projects, whereby the lancet-integrated sensor is ejected fromthe measuring device 11, and this ejected lancet-integrated sensor isdisposed of.

At this point of time, the connector 2 b of the lancet 2 is engaged withthe connector receiver 19 of the measuring device 11 although theejection lever 22 pushes the rear end of the sensor 1. Since the sensor1 is ejected first, a positional relationship between the sensor 1 andthe lancet 2 goes into a state shown in FIG. 2( d). Then, the fineprojections 2 c of the lancet 2 are engaged with the concave groove 60a, and the lancet-integrated sensor is ejected from the measuring device11 with the needle tip of the lancet 2 being completely housed in thesensor 1. Therefore, it is possible to prevent injury or infectiousdisease caused by the needle tip protruding from the sensor.

As described above, according to the first embodiment of the invention,since the sensor and the lancet are integrated with each other,management thereof is facilitated, and trouble of separately replacingthe sensor and the lancet at every use is saved. Further, since thesensor and the lancet can be simultaneously set in the measuring device,setting is facilitated, and this unit in its entirety is reduced in sizeand is easy to carry.

When the lancet-integrated sensor is ejected, in order to prevent injuryand infectious disease more reliably, a semi-circular space thatconforms to the shape of the front end of the sensor 1 is formed on aside of the grip part 3 a of the protection cover 3 as shown in FIG. 6(a), and the lancet-integrated sensor may be ejected with the sensor 1being covered with the protection cover 3 as shown in FIG. 6( b).

Further, while the lancet-integrated sensor according to the firstembodiment is provided with the protection cover that covers the tip ofthe lancet, the lancet-integrated sensor may be provided with a holderwhich covers a periphery of the lancet-integrated sensor and theprotection cover to hold these members. In this case, fitting of thelancet-integrated sensor to the measuring device and ejection of thesensor from the measuring device can be performed with the sensor beingcovered with the holder, and operation is eased for patients with manualimpairments.

When the holder is formed of a transparent material to make it easy tosee an internal lancet-integrated sensor, operability is furtherenhanced.

Furthermore, while in the first embodiment the lancet-integrated sensoruses space in which the needle tip of the lancet moves, also with regardto the cavity into which blood is drawn, the space and the cavity may beseparated. Further, while in this first embodiment the sensor is a thinplate in shape, the shape of the sensor is not restricted thereto, andthe sensor may be cylindrical in shape.

Furthermore, as shown in FIG. 7, the slide button 15 of the measuringdevice 11 may have wave-shaped projections and depressions on its uppersurface to prevent a finger from slipping, and a shape of the sensorinsertion slot 13 may approach a rectangle.

Embodiment 2

According to a second embodiment of the invention, when thelancet-integrated sensor is disconnected from the measuring device, thetip of the needle 2 a is reliably housed in the sensor to prevent thepossibility that a finger of another person touches the needle 2 a ontowhich a bodily fluid remains, or a person pricks his/her finger with theneedle 2 a by mistake, thereby avoiding infectious disease as well asproblems in terms of safety.

Hereinafter, a description will be given of a lancet-integrated sensor,and a measuring device which performs a measurement using thislancet-integrated sensor.

FIG. 8( a) is a perspective view illustrating an example of alancet-integrated sensor according to the second embodiment of theinvention.

With reference to FIG. 8( a), reference numeral 2 denotes a lancet forlancing skin of a man or an animal to extract bodily fluid. The lancet 2is composed of a connector 2 b which is made of an approximatelyrectangular-shaped plate member, and a needle 2 a for lancing the skin,which is provided at a head of the connector 2 b, i.e., in the vicinityof a center of a semi-circular-shaped shorter side of the connector 2 bhaving two shorter sides. In the vicinity of a center of two longersides of the connector 2 b, small-sized fine projections 2 c are formedat right angles from respective longer sides, and these fine projections2 c have, on their upper surfaces, fine concave portions 21 a and 21 b(concave portions for locking, locking members) which are somewhat longfrom side to side and have semi-cylindrical-shaped bottom surfaces.Reference numeral 1 denotes a sensor for analyzing extracted bodilyfluid. The sensor 1 has an internal cavity 1 a in which the lancet 2 isslidably housed. The sensor 1 has, at a ceiling of the cavity 1 a, fineconvex portions 61 a and 61 b (convex portions for locking, lockingmembers) which are somewhat long from side to side and havesemi-cylindrical-shaped surfaces, to be engaged with the fine concaveportions 21 a and 21 b provided on the fine projections 2 c of thelancet 2, respectively. Reference numeral 1 a denotes a cavity formed inthe sensor 1. The cavity 1 a has a width a little larger than a width ofthe lancet 2, and has a pair of concave grooves 60 a that project fromtwo longer sides of the cavity 1 a, in a width direction,correspondingly to the fine projections 2 c of the lancet 2. Referencenumeral 2 a denotes a needle for lancing the skin, which is provided ata front end 2 e of the lancet 2, i.e., in the vicinity of a center of asomewhat-rounded shorter side (head side) of two shorter sides of thelancet 2. Reference numeral 10 denotes a lancet-integrated sensor, inwhich the lancet 2 and the sensor 1 are integrated with each other.

FIG. 8( b) is an exploded perspective view illustrating an example of alancet-integrated sensor according to the second embodiment of theinvention.

As shown in FIG. 8( b), the lancet-integrated sensor 10 is constitutedby placing the lancet 2 between a cover 6 and a substrate 7 which arecomponents of the sensor 1, and bonding the cover 6 and the substrate 7together.

The cover 6 has a groove 6 a whose outline shape is a little larger thanthat of the lancet 2, and the groove 6 a forms a cavity 1 a in which thelancet 2 is to be housed slidably along its longitudinal direction. Inthe groove 6 a, concave grooves 60 a for restricting a region where thelancet 2 is slidable are formed on a rear portion of longer sides of thegroove 6 a so that a part with the concave grooves 60 a becomes a littlewider than another part of the groove 6 a, and a length of each concavegroove 60 a in a transverse direction is set according to a length ofthe fine projections 2 c of the lancet 2.

Further, as described above, the fine concave portions 21 a and 21 b ofthe lancet 2 are formed on the upper surfaces of the fine projections 2c which are formed in the vicinity of the center of the longer sides ofthe lancet 2, in positions most distant from the needle 2 a, i.e., inthe vicinity of edges of the projections 2 c on an opposite side fromthe needle 2 a. The fine convex portions 61 a and 61 b of the sensor 1are formed in ceilings of the concave grooves (hollows) 60 a of thecover 6, in positions most distant from the needle 2 a when thelancet-integrated sensor is assembled, i.e., in the vicinity of edges ofthe concave grooves 60 a on the opposite side from the needle 2 a.

Although a positional relationship between the fine concave portions 21a and 21 b and the fine convex portions 61 a and 61 b may be other thanmentioned above, these portions must be arranged with a predeterminedpositional relationship such that the needle 2 a of the lancet 2 ishoused in the sensor 1 when the fine concave portions 21 a and 21 b ofthe lancet 1 are engaged with the fine convex portions 61 a and 61 b ofthe concave grooves 60 a of the cover 6.

Further, a front end of the cover 6, i.e., a shorter side of the cover 6facing the needle 2 a of the lancet 2, is semi-circular in shape, and agroove 6 b, an end of which is connected to the groove 6 a, is formed atthe front end of the cover 6 so that the needle 2 a at front end 2 eprojects from the sensor 1, and another end of the connecting groove 6 bis an opening 6 d of the front end of the sensor 1. An opening 6 c isalso formed on a rear end of the cover 6, i.e., an end of the cover 6 onthe side opposite to the needle 2 a of the lancet 2, so that theconnector 2 b of the lancet 2 projects from the sensor 1, and notches 21a and 21 b are formed at two corners of the rear end of the cover 6 sothat electrode terminals 4 are exposed.

Although a front end of the substrate 7 is semi-circular in shape likethe cover 6, the substrate 7 has no notches on a the rear end unlike thecover 6. On a surface of the substrate 7, the two electrode terminals 4are formed at two corners of rear ends of the longer sides, and a pairof electrodes 8 connected to the electrode terminals 4 by wiring areformed in the vicinity of a center of the semi-circular part on thefront end of the substrate 7. Further, a reagent layer (not shown) isformed on a surface of the electrodes 8. The lancet-integrated sensor 10is completed by bonding the cover 6 to the substrate 7, with the lancet2 being housed in the groove 6 a of the cover 6 as described above.

A protection cover 3 is fitted to the lancet-integrated sensor accordingto the second embodiment of the invention as shown in FIGS. 2( a) and2(b). Further, a measuring device for the lancet-integrated sensoraccording to the second embodiment of the invention has the same outwardshape as that shown in FIGS. 3( a) and 3(b). An internal structure ofthe measuring device is the same as that shown in FIGS. 4( a) and 4(b)and FIGS. 5( a), 5(b), and 5(c).

Next, a series of measuring operations of the lancet-integrated sensorand the measuring device which are completed as described above, will bedescribed.

Initially, an operation of attaching the lancet-integrated sensor to themeasuring device will be described. In a state where thelancet-integrated sensor is not used, the lancet 2 is placed in such aposition that the needle tip projects from the sensor 1, and the needletip is covered with the protection cover 3, as shown in FIG. 2( a). Theprotection cover 3 is composed of a tube 3 b as a needle housing part,and an approximately-square-shaped grip part 3 a. A user holds this widegrip part 3 a of the protection cover 3, and inserts a rear end of theconnector 2 b of the lancet 2 (an end of the lancet 2 opposite to theneedle) from opening 13 a of insertion slot 13 of the measuring device11, as shown in FIG. 2( a).

At this time, as shown in FIG. 5( a), the rear end of the connector 2 bof the lancet 2 is guided by guide (guide member) 17 in the measuringdevice 11, and goes toward concave portion 19 a of a front end ofconnector receiver 19. The connector receiver (lancet pushing member) 19is pressed in opposite directions by coil spring 18 and torsion spring21, and stands still in a position where pressing forces are balanced.

As the user continues to insert the lancet-integrated sensor 10 with thelancet 2 being covered with the protection cover 3, initially the lancet2 is gradually inserted together with the sensor 1 to reach a positionwhere it contacts ejection lever 15 that is united with slide button 14.Thereafter, when the slide button 14 reaches an end of its movable range(display 13 side) that is restricted by the termination member 17 a ofthe guide 17, the sensor 1 stops its backward movement. On the otherhand, the lancet 2 moves back in the sensor 1 while the user pushes theprotection cover 3.

When the lancet 2 reaches an end of its movable range in the sensor 1,the fine concave portions 21 a and 21 b of the lancet 2 are engaged withthe fine convex portions 61 a and 61 b of the cover 6 of the sensor 1 asshown in FIG. 2( b), whereby the lancet 2 is locked with respect to thesensor 1. At this time, the rear end of the lancet 2 is engaged with theconcave portion 19 a of the connector receiver 19, and the connectorreceiver 19 moves back as the user continues to push the protectioncover 3, and the tapered projection 20 a of the driving lever 20 that isfixed to the connector receiver 19 is engaged with the taperedprojection 11 a that is provided at the ceiling in the measuring device11 as shown in FIG. 5( b), whereby the connector receiver 19 is locked.In this state, attachment of the lancet-integrated sensor 10 to themeasuring device 11 is completed.

Next, a blood collecting operation and a blood dropping operation willbe described. When attachment of the lancet-integrated sensor to themeasuring device is completed, the vicinity of a semi-circular headportion of the sensor 10 is slightly exposed from the holder 13 as shownin FIG. 3( a). The user holds the measuring device 11, and lightlypresses the front end of the sensor 10 against a portion of his/her bodyfrom which blood is to be extracted, such as a fingertip.

When the user pushes push button (unlocking member) 14, the taperedprojection 20 a of the driving lever 20 and the tapered projection 11 cof the measuring device 11 are disengaged from each other, and thelancet 2 and the sensor 1 are unlocked by extension of the coil spring18, whereby the lancet 2 is driven (refer to FIG. 10) and, as shown inFIG. 2( c), the needle tip projects from the front end of the sensor 1to lance skin. At this time, an amount of projection of the needle tipfrom the sensor is variable by adjustment button 16 shown in FIG. 3( b).To be specific, the torsion spring 21 is moved in a horizontal directionin the measuring device 11 by sliding the adjustment button 16 in thehorizontal direction, thereby to adjust a spring force. Alternatively, adistance between the connector receiver 19 that is engaged with the pushbutton 14, and spring stopper 23 is increased or reduced by driving amechanism (not shown) for converting motion of the adjustment button 16in the horizontal direction into a to-and-fro motion of the springstopper 23 along a driving direction of the lancet 2. The amount ofprojection can be displayed on display unit 12 by converting an amountof sliding of the adjustment button 16 to the amount of projection, witha CPU or the like of the measuring device.

A small amount of blood that is oozing from a lanced fingertip of apatient or a person being tested is dropped onto the front end of thesensor 1, and the blood is drawn into the cavity 5. The measuring device11 measures blood sugar by an internal electronic circuit, and displaysa result of this measurement on the display unit 12. When the result ofmeasurement is displayed to complete measurement, the user operates theslide button (ejection member) 15 to eject the lancet-integrated sensor10 from the measuring device 11, and this ejected lancet-integratedsensor 10 is disposed of.

At this time, the ejection lever (ejection member) 22 that is unitedwith the slide button 15 pushes the sensor 1 from its rear end. At abeginning of pushing, the connector 2 b at the rear end of the lancet 2is engaged with the concave portion 19 a of the connector receiver 19 ofthe measuring device 11. Therefore, the sensor 1 is ejected before thelancet 2 by operating the slide button 15. Accordingly, a positionalrelationship between the sensor 1 and the lancet 2 becomes as shown inFIG. 5( b). That is, the fine concave portions 21 a and 21 b of thelancet 2 are engaged with the fine convex portions 61 a and 61 b of theconcave grooves 60 a and 60 b of the sensor 1, and the lancet 2 islocked in the state where its needle tip does not project from thesensor 1. When the slide button 14 is further pushed, the lancet 2 withthe needle tip 2 a being locked in the sensor 1 is ejected together withthe sensor 1 from the measuring device 11. Therefore, the needle 2 a ofthe lancet 2 is not exposed from the sensor 1, thereby preventing injuryor infectious disease caused by the needle tip being exposed.

As described above, according to the second embodiment of the invention,the lancet-integrated sensor is ejected in a state where the lancet 2and the sensor 1 are reliably locked with each other. At this time, thelancet 2 and the sensor 1 are locked with the needle 2 a of the lancet 2being housed in the sensor 1. Therefore, when taking thelancet-integrated sensor 10 out of the measuring device, there is nopossibility that the user touches the needle 2 a of the lancet 2 withhis/her finger, or pricks the finger with the needle 2 a by mistake,thereby preventing infectious diseases. As a result, a lancet-integratedsensor which can be safely ejected from the measuring device isobtained.

Furthermore, it is possible to obtain a measuring device for alancet-integrated sensor, which can measure bodily fluid with such asafely-detachable lanced-integrated sensor, and can eject thelancet-integrated sensor with the lancet being locked in a state wherethe needle of the lancet is housed in the sensor, when measurement isended.

While in this second embodiment a concave portion is provided on theupper surface of the lancet and a convex portion that is engaged withthe concave portion is provided on the sensor 2, the positions where theconcave portion and convex portion are provided may be arbitrarily setas long as the lancet and the sensor are locked by engagement of theconcave portion with the convex portion after end of measurement, andthe needle of the lance is housed in the sensor.

Embodiment 3

According to a third embodiment of the present invention, a holder forguiding a lancet-integrated sensor into a measuring device is detachablefrom the measuring device to enable cleaning or the like of the holder.

To be specific, when a patient extracts bodily fluid using the measuringdevice with the lancet-integrated sensor according to the first orsecond embodiment, the patient must apply his/her finger or upper arm toholder-shaped insertion slot 13 of the measuring device 11 to lanceskin, and the bodily fluid of the patient sometimes sticks to theinsertion slot 13 of the measuring device 11.

However, since, in the measuring device according to the first or secondembodiment, the measuring device 1 is united with the insertion slot 13,the insertion slot 13 cannot be cleaned or replaced after measurement.Therefore, if another patient performs measurement with the measuringdevice in which another's bodily fluid remains on the insertion slot 13,bodily fluid of the patient might contact the another's bodily fluid,resulting in fear of infectious diseases or the like. Accordingly, themeasuring device of the first or second embodiment can be used forpersonal measurement only.

On the other hand, the measuring device for the lancet-integrated sensoraccording to the third embodiment enables a user to clean or replace theinsertion-slot-shaped holder to which the bodily fluid sticks, wherebythe user can handle the measuring device safely and cleanly.

FIGS. 11( a), 11(b) and 12(a)-12(c) are diagrams illustratingconstruction of the measuring device for the lancet-integrated sensor,according to the third embodiment of the invention.

FIG. 11( a) is a perspective view of a lancet-integrated sensor and ameasuring device to be combined with the sensor, and FIG. 11( b) shows astate when a holder is disconnected.

In FIGS. 11( a) and 11(b), reference numeral 11 denotes a measuringdevice for a lancet-integrated sensor (hereinafter referred to as ameasuring device) for measuring blood sugar or the like with alancet-integrated sensor 2 that is fitted thereto, and reference numeral10 denotes a lancet-integrated sensor.

The measuring device 11 has a holder attachment part 47 on a side wallwhere the lancet lances skin, and a holder body 43 for holding an endportion of the lancet-integrated sensor 10 in the vicinity of a sidewhere the lancet lances the skin is detachably attached to the holderattachment part 47. Further, the measuring device 11 has an operationbutton 14 for driving the lancet that is fitted thereto, a display 12for displaying a measurement result or the like, a slide button 15 forejecting the lancet-integrated sensor 10 from the measuring device 11,and a holder attachment part 47 to which the holder body 43 is attached.

As shown in FIG. 11( b), the holder body 43 is detachable from themeasuring device 11 so that bodily fluid that sticks to the holder body43 can be washed away or the holder body 43 can be replaced with anotherone after completion of measurement.

Further, as already described above, the lancet-integrated sensor 10 isconstituted by integrating the lancet 2 for lancing the skin of a man oran animal to extract bodily fluid, and the sensor 1 for analyzing thisextracted bodily fluid.

Hereinafter, constructions of the holder body 43 and the holderattachment part 47 will be described in more detail, with reference toFIGS. 12( a)-12(c).

FIGS. 12( a)-12(c) are diagrams for explaining attachment/detachment ofthe holder body 43 to/from the holder attachment part 47.

With reference to FIG. 12( a), reference numerals 43 a and 43 b denotehinge-shaped stoppers possessed by the holder body 43. These stoppersare formed by bending plate members, which are extended forward fromboth ends of the holder body 43, i.e., in a direction opposite to adirection along which the lancet-integrated sensor is inserted, backwardat approximately 180°. The stoppers 43 a and 43 b have, at their frontends, clip parts 43 e and 43 f which serve as retainers of the stoppers43 a and 43 b, and perform positioning when the holder body 43 isstopped at opening 47 c, respectively. Inner sides of the hinge-shapedstoppers are fixed onto the holder body 43, and outer sides of thehinge-shaped stoppers are engaged with engagement parts of the holderattachment part 47, whereby the holder body 43 is stopped by connectingit to the measuring device 11. That is, the holder body 43 is stopped,with its spring force, at holes (small openings) 47 a and 47 b which areformed at two shorter sides of the holder attachment part 47 having anopening shape approximately equal to an outer shape of the holder body43 so as to increase a width of the holder attachment part 47 to someextent. The holes 47 a and 47 b may be formed at two longer sides of theopening 47 a of the approximately-rectangular holder attachment part 47.

The holder body 43 can be attached to the holder attachment part 47 ofthe measuring device 11 by inserting the stoppers 43 a and 43 b of theholder body 43 into the holes 47 b and 47 b of the holder attachmentpart 47, respectively. As shown in FIG. 12( a), the holes 47 a and 47 bof the holder attachment part 47 have different sizes and the stoppers43 a and 43 b of the holder body 43 have different sizes, whereby theholder body 43 cannot be inserted upside down. A reason for this is asfollows. If the lancet-integrated sensor 10 is inserted upside down intothe measuring device 11, electrical connection between thelancet-integrated sensor 10 and the measuring device 11 cannot be made.In order to avoid this problem, right and left holes of the holderattachment part 47 are formed in different shapes and the right and leftstoppers of the holder body 43 are also formed in different shapes, sothat the holder body 43 can be inserted into the holder attachment part47 only when its up-to-down direction is a certain direction, i.e., anormal direction, whereby the lancet-integrated sensor 10 cannot beinserted upside down.

FIG. 12( b) and FIG. 12( c) are cross-sectional views in a case wherethe holder body 43 is stopped by connecting it to the measuring device11. FIG. 12( b) shows a state where the hinge-shaped stoppers 43 a and43 b of the holder body 43 are engaged with the holes 47 a and 47 b ofthe measuring device 11. Further, FIG. 12( c) shows a state where a usertries to detach the holder body 43 by pressing the clip portions 43 eand 43 f of the stoppers 43 a and 43 b with fingers to replace theholder body 43, after measurement is completed or when another personuses the measuring device 11.

Since the holder for attaching the lancet-integrated sensor, which ispossessed by the measuring device, is detachable as described above, theholder body onto which bodily fluid sticks can be replaced with anunused one or washed, whereby the measuring device can be used not onlyby a specific user but also by anyone other than the user, without fearof infectious diseases or the like. Therefore, the measuring device forthe lancet-integrated sensor can be used safely and cleanly.

Further, since the holder body is provided with the hinge-shapedstoppers to be engaged with the holder attachment part, fixation andattachment/detachment of the holder body can easily be performed.

Furthermore, since the holes of the holder attachment part havedifferent shapes and the stoppers of the holder body also have differentshapes, the holder body can always be attached in a normal direction tothe measuring device, thereby preventing the lancet-integrated sensorfrom being inserted upside down into the measuring device.

While in this third embodiment shapes of the left and right stoppers 43a and 43 b of the holder body 43 are different from each other andshapes of the left and right holes 47 a and 47 b of the holderattachment part 47 are also different from each other, these engagementparts of the holder body and the holder attachment part may havearbitrary shapes as long as respective engagement parts are asymmetricalin a vertical or horizontal direction so that the holder body can beattached to the holder attachment part only when the holder body isinserted in a predetermined direction.

Furthermore, the spring stopper 23 of the measuring device 11 may befixed to a ceiling of the measuring device 11 as shown in FIG. 13( a),and the coil spring 18 may be attached to a shaft 56 a that is fixedonto the spring stopper 23.

Furthermore, the lancet-integrated sensor 10 may have a shape that is alittle shorter in a longitudinal direction as shown in FIG. 13( b).

Embodiment 4

According to a fourth embodiment of the present invention, an amount ofprojection of a needle tip from a lancet-integrated biosensor can beeasily adjusted. Further, when the lancet is driven so as to project outforcibly, if drive is stopped halfway due to some trouble, the lancetcan easily be returned to a state before being driven.

To be specific, in the measuring device for the lancet-integrated sensoraccording to the first or second embodiment, when extraction of bodilyfluid is performed, the driving member 100 is operated by pushing downthe operation button 14 to drive the lancet 2 so that the needle 2 alances a fingertip or upper arm, and extracted blood is dropped onto thesensor 1 to perform measurement of the blood. However, when extractionof bodily fluid cannot be performed due to some trouble such asinsufficient lancing by the lancet, the lancet 2 must be reset to astate where the lancet 2 can be driven again.

However, in order to reset once driven lancet 2 to the state where itcan be driven again, the lancet-integrated sensor 10 must be onceejected by using the slide button 15 and, thereafter, reattached to themeasuring device 11. It is sometimes necessary to replace thelancet-integrated sensor 10 itself.

Further, since the lancet-integrated sensor according to the first orsecond embodiment is not provided with an effective device for adjustingthe amount of projection of the needle tip of the lancet, it isdifficult to adjust an amount of bodily fluid oozing from a patient orreduce pain of the patient.

On the other hand, the measuring device for the lancet-integrated sensoraccording to the fourth embodiment can easily adjust the amount ofprojection of the needle tip of the lancet, and it can performre-preparation for measurement when bodily fluid cannot be extracted dueto some trouble such as insufficient lancing by the lancet.

Hereinafter, a measuring device for the lancet-integrated sensoraccording to the fourth embodiment will be described.

FIG. 14 is a diagram illustrating an example of the measuring deviceaccording to the fourth embodiment of the present invention.

With reference to FIG. 14, reference numeral 11 denotes a measuringdevice for a lancet-integrated sensor (hereinafter referred to as ameasuring device) according to the fourth embodiment of the invention.Reference numeral 13 denotes an insertion slot into which thelancet-integrated sensor is inserted, and the insertion slot is appliedto a finger or upper arm of a patient when measurement is performed;numeral 14 denotes an operation button for driving the lancet that isfitted to the measuring device 11; numeral 12 denotes a display fordisplaying a result of measurement or the like; numeral 15 denotes aslide button for ejecting the lancet-integrated sensor from themeasuring device 11; numeral 56 denotes a pull stick for returning thelancet-integrated sensor back to a stand-by position where measurementcan be performed with the lancet-integrated sensor being fitted to themeasuring device 11, by pulling the lancet-integrated sensor in adirection opposite to the lancet driving direction, i.e., in a directionshown by arrow A in FIG. 14, when some trouble occurs in extractingbodily fluid; and numeral 57 denotes a lancet projection amount adjusterfor adjusting the amount of projection of the needle tip of the lancet,which also serves as a stopper of the pull stick 56.

FIG. 15 is a cross-sectional view taken along line X-X′, of themeasuring device for the lancet-integrated sensor shown in FIG. 14. InFIG. 15, the pull stick 56 has a handle part 56 d. The same constituentsas those described with respect to FIG. 14 are given the same referencenumerals to omit description thereof.

In FIG. 15, reference numeral 10 denotes a lancet-integrated sensorfitted to the measuring device 11, which is constituted by integratingthe lancet 2 for lancing skin of a man or an animal to extract bodilyfluid, and sensor 1 for analyzing this extracted bodily fluid.

Further, reference numeral 19 denotes a connector receiver having aconcave portion 19 a that is engaged with a connector 2 b possessed bythe lancet 2 as a component of the lancet-integrated sensor 10.Reference numeral 56 a denotes a shaft, and the connector receiver 19for receiving an end of the lancet 2, which end is opposed to a sidewhere the skin is lanced, is fixed to an end of the shaft 56 a, whichend is opposite to the side where the skin is lanced. An end (slip-outprevention member) 56 b of the shaft 56 a, which is positioned withinthe pull stick 56, has a diameter larger than a diameter of an opening56 c of the pull stick 56. Reference numeral 20 denotes a driving leverwhich is provided on the connector receiver 19, and the driving lever 20stops movement of the connector receiver 19 against a force by which theconnector receiver 19 is moved in a direction along which the lancet 2lances the skin, by spring 18 which is fitted to the shaft 56 a that isunlocked by pressing the operation button 14 for starting operation ofdriving member 100. The operation button 14, the pull stick 56, thelancet projection amount adjuster 57, the shaft 56 a, and the connectorreceiver 19 constitute the driving member 100 which drives the lancet 2from its stand-by position along the longitudinal direction of thesensor 1, i.e., the direction along which it lances the skin and,thereafter, returns the lancet back to the stand-by position, with thelancet-integrated sensor 10 being fitted to the measuring device 11.

Next, operation will be described.

First of all, a patient pushes the lancet-integrated sensor 10 into thesensor insertion slot 13 of the measuring device 11, whereby theconnector 2 b possessed by the lancet 2 of the lancet-integrated sensor10 is engaged with the concave portion 19 a of the connector receiver19, and a tapered projection (claw portion) 20 a of the driving lever 20fixed to the connector receiver 19 is engaged with a tapered projection(claw portion) 11 c of the measuring device 11 so that the lancet 2 canbe shot by pressing down the operation button 14.

Thereafter, the patient applies the insertion slot 13 of the measuringdevice 11 to his/her finger or upper arm, and presses the operationbutton 14, whereby the tapered projection 20 a of the connector receiver19 is disengaged from the tapered projection 11 c of the measuringdevice 11, and the lancet 2 is shot from the tip of the sensor 10.

At this time, if the lancet 2 fails to lance the skin or measurementdoes not go well due to some trouble, the user picks the pull stick 56and pulls it in the direction of the arrow shown in FIG. 14, i.e.,upward in the Figure, whereby the end 56 b of the shaft 56 a is pulledup, and the connector receiver 19 holding the connector 2 b of thelancet 2 is operated in synchronization with the shaft 56 a. Thus, thetapered projection 20 a provided on the connector receiver 19 can bere-engaged with the tapered projection 11 c just before the operationbutton 14.

Further, when the lancet 2 is shot, the lancet 2 moves along thelongitudinal direction of the sensor 1, and the pull stick 56 that isoperated in synchronization with the lancet 1 moves until reaching anopposed surface of the lancet projection amount adjuster 57. The lancetprojection amount adjuster 57, which serves as a stopper for the pullstick 56, has a structure of a screw thread to be screwed into a screwhole 11 d that is formed on a side of the measuring device 11 oppositeto the insertion slot 13. The lancet projection amount adjuster 57 canbe moved along a lancet moving direction by rotating it clockwise orcounterclockwise.

Therefore, the measuring device 11 adjusts a position of the lancetprojection amount adjuster 57 in advance of driving the lancet 2, andadjusts a spring force by adjusting a distance between the connectorreceiver 19 and the spring stopper (supporting member) 23, therebysetting the amount of projection of the needle 2 a of the lancet 2 to adesired amount. Thus, shot lancet 2 moves until the pull stick 56 hitsthe lancet projection amount adjuster 57 to stop, whereby the amount ofprojection of the needle tip of the lancet 2 from the sensor can beadjusted.

As described above, according to the fourth embodiment, even when thelancet 2 fails to lance the skin or measurement does not go well due tosome trouble, preparation for re-measurement can be easily performedusing the pull stick 56 which sets the connector receiver 19 holding theconnector 2 b of the lancet 2, beneath the operation button 14 again tobring the measuring device into a state where measurement can beperformed.

Furthermore, since the measuring device 11 is provided with the lancetprojection amount adjuster which can adjust the amount of projection ofthe lancet, an amount of bodily fluid oozing from a patient can beadjusted, or pain of the patient can be reduced.

Embodiment 5

A fifth embodiment according to the present invention provides abiosensor cartridge, by which a biosensor or a lancet-integrated sensorcan be fitted to a measuring device without a troublesome operation.

Hereinafter, a biosensor cartridge according to the fifth embodiment ofthe invention will be described taking, as an example, a cartridge whichhouses biosensors for electrochemically measuring blood sugar, withreference to the drawings.

FIG. 16 is a diagram illustrating a biosensor cartridge according to thefifth embodiment of the invention.

In FIG. 16, reference numeral 1 denotes biosensors for measuring bloodsugar, and each biosensor 1 is formed of a plate member that isapproximately rectangular in shape, and one of two shorter sides ofrectangular biosensor 1 is semi-circular in shape. Reference numeral 11denotes a measuring device for measuring blood sugar with the biosensor1 attached thereto. Reference numeral 63 denotes a biosensor cartridgecomprising plastic or the like, and the cartridge 63 has anapproximately-rectangular-parallelepiped housing box (cartridge body) 63c, and plural housing sections 63 b which are slits each conforming tothe shape of the biosensor 1. The housing sections 63 b can hold pluralbiosensors 1 separately, by perpendicularly supporting the biosensors 1with their end portions to be inserted into the measuring device 11facing up. A spacing between the housing sections (slits) 63 b forhousing the biosensors 1 should be sufficiently large so that insertionslot 11 a of the measuring device 11 can be pressed onto each of theseseparately housed biosensors 1. That is, when inserting a targetbiosensor 1 into the insertion slot 11 a of the measuring device 11,this spacing prevents the insertion slot 11 a from contacting biosensorsadjacent to a target biosensor. Reference numeral 63 a denotes a lid(lid part) of the biosensor cartridge 63. The lid 63 a is hollow andapproximately rectangular-parallelepiped in shape, and the lid 63 a isopened or closed by rotating it about 90 degrees about a hinge 63 h thatis provided on a side of the housing box 63 c.

FIGS. 17( a) and 17(b) are diagrams illustrating a state where one ofthe biosensors housed in the biosensor cartridge of the fifth embodimentis inserted into the measuring device.

Attachment of the biosensor 1 to the measuring device 11 is performed asfollows. After the lid 63 a of the biosensor cartridge 63 is opened asshown in FIG. 16, the biosensor 1, which is stored in the biosensorcartridge 63 with its semi-circular end facing up, is inserted into thebiosensor insertion slot 11 a of the measuring device 11 as shown inFIGS. 17( a) and 17(b).

At this time, the spacing between the housing sections 63 b for housingthe biosensors 1 is set so that, when a target biosensor 1 is insertedinto the insertion slot 11 a of the measuring device 11, the insertionslot 11 a does not contact the biosensors adjacent to the targetbiosensor. Therefore, the target biosensor 1 can be easily attached tothe measuring device 11 without damaging other biosensors 1.

As described above, according to the biosensor cartridge of the fifthembodiment, the spacing between respective housing sections provided inthe biosensor cartridge is sufficiently large so that one of separatelystored biosensors 1 can be inserted into the insertion slot 11 a of themeasuring device 11. Therefore, the biosensor 1 can be inserted into themeasuring device 11 with a single touch, whereby preparation formeasurement can be easily performed. Consequently, each of thebiosensors stored in the cartridge can be inserted into the measuringdevice 11 without a troublesome operation, and it is possible tominimize such accident that the insertion slot 11 a of the measuringdevice contacts the biosensors adjacent to the target biosensor therebyto damage the biosensors.

Modification 1 of Embodiment 5

Hereinafter, a biosensor cartridge according to a first modification ofthe fifth embodiment will be described. The biosensor cartridgeaccording to this first modification is characterized in a manner ofhermetically sealing the cartridge. Since other constituents areidentical to those described for the fifth embodiment, the samereference numerals are given to the constituents to omit descriptionthereof.

FIGS. 18( a)-18(c) are diagrams illustrating a biosensor cartridgeaccording to the first modification of the fifth embodiment.

As shown in FIG. 18( a), in the biosensor cartridge 63, anapproximately-rectangular-parallelepiped lid 63 a having a hollow insideis rotatably fixed onto an approximately-rectangular-parallelepipedhousing box 63 c with a hinge whose rotational axis is slidable in alongitudinal direction of the lid 63 a.

The hinge is composed of a pair of axial projections 63 g which projectin a vertical direction with respect to side surfaces forming longersides of the lid 63 a from vicinities of both ends of a shorter side ofthe opening of the lid 63 a; a side-to-side-long bearing 63 i whichextends within the same plane as side surfaces along the longer sides ofthe opening of the housing box 63 c from vicinities of the both ends ofthe shorter side of the opening; and a bearing hole 63, which is formedin the bearing 63 i in an oval shape, with which the axial projections63 g are engaged.

Then, four reverse-L-shaped projections 63 d which are formed at edgesof respective sides of the opening of the lid 63 a are positioned atfour notches 63 e formed in a projection part (peripheral edge part) 63f which is formed at edges of respective sides of an upper surface ofthe housing box 63 c of the biosensor cartridge 63, and the projections63 d are received within the notches 63 e. Then, the lid 63 a is rotatedby 90° in a direction indicated by an arrow (i.e., counterclockwise)and, thereafter, slightly slid in a radial direction (i.e., left forwarddirection in FIG. 18( a)), whereby the L-shaped projections 63 d areengaged with the projection part 63 f in the vicinity of the notches 63e, and the lid 63 a seals the housing box 63 c having the plural housingslits, of the biosensor cartridge 63. FIG. 18( b) is a side viewillustrating a state where the housing box is sealed with the lid, froma state shown in FIG. 18( a).

Further, FIG. 18( c) is a cross-sectional view illustrating a statewhere an elastic member (sealing member) 64 is disposed on a part wherethe housing box 63 c and the lid 63 a closely contact each other (i.e.,on a peripheral edge part of the opening of the lid 63 a) tohermetically seal the container. The elastic member 64 is a memberhaving large elasticity such as rubber. In this way, hermeticity of thebiosensor cartridge can be increased by integrally forming the elasticmember 64.

Although the shape of the biosensor housing part is not particularlydescribed above, plural slits, each conforming to the shape of thebiosensor, may be formed at regular intervals in a member that fills aconcave portion of the approximately-rectangular-parallelepiped housingbox 63 c. Thereby, the biosensors can be perpendicularly supported atregular intervals so that, when inserting the target biosensor 1 intothe insertion slot 2 a of the measuring device 2 as in the fifthembodiment, the insertion slot 2 a does not contact adjacent biosensors.

As described above, according to the first modification of the fifthembodiment, the elastic member 64 or the like is formed integrally withthe engagement part of the housing box 63 c and the lid 63 a of thebiosensor cartridge 63, and the housing box 63 c is covered with the lid63 a. Thereafter, the L-shaped projections 63 d provided on the lid 63 aare received within the notches 63 e of the projection part 63 f of thebiosensor cartridge, and the L-shaped projections 63 d are slid to beengaged with the notches 63 e, thereby hermetically sealing thecontainer. Therefore, the hermeticity of the container is increased, andmoisture in the container is reduced, whereby the sensor is preventedfrom being contaminated by the moisture, leading to improvement inaccuracy of the sensor.

Modification 2 of Embodiment 5

FIG. 19 is a diagram illustrating a biosensor cartridge according to asecond modification of the fifth embodiment of the present invention.

In FIG. 19, reference numeral 10 denotes a lancet-integrated sensorwhich is constituted by integrating a lancet for lancing skin of a manor an animal to extract bodily fluid, and a sensor for analyzingextracted bodily fluid; reference numeral 11 denotes a measuring devicefor measuring blood sugar or the like with a lancet-integrated sensor 5that is attached thereto; and reference numeral 63 denotes a biosensorcartridge comprising plastic or the like, which is composed of anapproximately-rectangular-parallelepiped lid 63 a and anapproximately-rectangular-parallelepiped housing box 63 c. The housingbox 63 c is provided with lower grooves 630 a, intermediate grooves 630b, and upper grooves 630 c so as to support the lancet-integratedsensors 10, each having a protection cover (protector) 3 on its bottomsurface, perpendicularly at regular intervals. To be specific, the lowergrooves 630 a, into which protection covers 3 of the lancet-integratedsensors 10 are inserted to be supported, are formed at a side nearest toa bottom of a member that fills up a concave portion of the housing box63 c. The intermediate grooves 630 b, into which portions of thelancet-integrated sensors 10 are inserted to be supported, are formedabove the lower grooves. The upper grooves 630 c are formed above theintermediate grooves, and lowermost portions of the upper grooves 630 care a little rounded to increase widths of these grooves, andapproximately entire portions thereof are wider than widths of thesensors of the lancet-integrated sensors 10. A single housing part(groove) 63 b is formed of a lower groove (first groove) 630 a, anintermediate groove (second groove) 630 b, and an upper groove (thirdgroove) 630 c which are connected with each other. In the housing box 63a, the lancet-integrated sensors 10 are respectively housed in theplural housing parts 63 b at regular intervals, with portions to beinserted to the measuring device 11 facing upwardly.

A spacing between the housing parts for housing the lancet-integratedsensors should be sufficiently large so that the insertion slot 11 a ofthe measuring device 11 can be pressed onto each of separately storedlancet-integrated sensors 10. As an example of the lancet-integratedsensor, the lancet-integrated sensor which has already been describedfor the first or second embodiment may be employed.

FIG. 20( a) is a constitutional diagram for explaining attachment of alancet-integrated sensor to a measuring device, and FIG. 20( b) is aperspective view thereof.

FIG. 20( a) shows a lancet-integrated sensor having a needle storagepart that is a little wider than those shown in FIG. 1 and otherfigures.

Attachment of the lancet-integrated sensor 10 to the measuring device 11is performed as follows. After the lid 63 a of the biosensor cartridge63 is opened as shown in FIG. 19, the lancet-integrated sensor insertionslot 11 a of the measuring device 11 is pressed onto thelancet-integrated sensor 1 that is stored in biosensor cartridge 63 asshown in FIG. 20( b).

As described above, according to the fifth embodiment, a spacing betweenrespective storage parts of the biosensor cartridge is sufficientlylarge so that the insertion slot 11 a of the measuring device 11 can bepressed onto one of the lancet-integrated sensors 10 that are storedseparately, whereby the lancet-integrated sensor 10 can be inserted intothe measuring device 11 by a single touch, and preparation formeasurement can be easily performed as compared with a measuring devicefor the sensor having no lancet. Therefore, each of the biosensorsstored in the housing case can be inserted into the measuring device 11without performing a troublesome operation, and the insertion slot 11 aof the measuring device 11 is prevented from contacting the biosensorsadjacent to the target biosensor, to thereby prevent damage to thebiosensors.

Although the biosensors are perpendicularly supported in the first orsecond modification of the fifth embodiment, when a height of thebiosensor cartridge should be reduced, the biosensors may be supportedin a slanting direction. Also in this case, the same effects asmentioned above are achieved by providing biosensor storage parts atregular intervals with which the insertion slot of the measuring devicecan be pressed onto a target biosensor without damaging adjacentbiosensors.

APPLICABILITY IN INDUSTRY

As described above, according to a lancet-integrated sensor of thepresent invention and a measuring device to be combined with the sensor,a sensor and a lancet are integrated, and a measuring device formeasuring characteristics of bodily fluid is provided with a function ofdriving the lancet. Therefore, as compared with a conventional systemcomprising a sensor, a lancet, a measuring device, and a lancet device,a number of components is reduced, whereby management is facilitated.Especially, it is not necessary to manage a number of disposal sensorsand lancets separately. Further, when carrying these devices, volume isreduced, resulting in convenience of portability.

Further, when preparing for measurement, it is not necessary to set asensor on a measuring device and a lancet on a lancet device,respectively, as is conventional, and preparation for measurement can becompleted by only a single operation of setting a lancet-integratedsensor onto a measuring device. Further, trouble associated withreplacing a used sensor with a new one is reduced by half.

Furthermore, since a lancet is locked with its needle tip being housedin a sensor, an accident due to careless exposure of the needle tip isavoided.

Moreover, since a cartridge for housing plural sensors can supportsensors at regular intervals, it is possible to avoid such an accidentthat, when a sensor is attached to a measuring device, the measuringdevice damages other sensors.

1-43. (canceled)
 44. A biosensor cartridge for housing pluralbiosensors, each having a reagent layer for detecting a specificcomponent in bodily fluid of a subject, and an electrode for taking outan electric signal indicating that the reagent layer detects thespecific component, wherein a cartridge body has, at an end of its uppersurface, a hinge for rotatably fixing a lid that covers the cartridge;the cartridge body has plural slits for perpendicularly supporting therespective biosensors; and the plural slits are formed in parallel witheach other, from the upper surface toward the lower surface of thecartridge body, at regular intervals which allow an insertion slot of ameasuring device for performing measurement using a target biosensor tobe inserted without touching biosensors adjacent to the targetbiosensor.
 45. A biosensor cartridge as defined in claim 44, wherein thecartridge body to which the lid is attached is a rectangularparallelepiped in shape.
 46. A biosensor cartridge as defined in claim45, wherein the lid is a hollow rectangular parallelepiped in shape, andhas an opening at a portion opposed to the upper surface of thecartridge body.
 47. A biosensor cartridge as defined in claim 44,wherein the bottom of each slit has a shape that conforms to the shapeof the front end of the biosensor.
 48. A biosensor cartridge as definedin claim 47, wherein the front end of the biosensor is semi-circular inshape.
 49. A biosensor cartridge as defined in claim 44, wherein thehinge is constituted by a pair of bearings each having a side-to-sidelong bearing hole that projects outward along the longitudinal directionof the cartridge body from an end of the upper surface of the cartridgebody, and a pair of axial projections which are provided at an end ofthe lid, and serve as fulcra when being smooth-movably engaged with thebearings to rotate the lid; a peripheral edge part is formed at theperiphery of the upper surface of the cartridge body, which part extendsin a direction perpendicular to the side walls of the cartridge body,and has plural notches; reverse-L-shaped projections are formed on thesame plane as the side walls of the lid, in positions corresponding tothe notches of the peripheral edge part, at the periphery of the openingof the lid; and a sealing member having elasticity is formed on theupper surface of the peripheral edge part. 50-58. (canceled)